FDA Medical Device Recalls (openFDA)
Shimadzu Medical Systems: Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table.
- Recall number
- Z-0251-2016
- Recalling firm
- Shimadzu Medical Systems
- Product
- Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table.
- Status
- Terminated
- Initiated
- 2015-09-30
- Posted
- not on file
- Terminated
- 2016-09-12
- Reason
- The C-arm may interfere with the table top under certain circumstances.
- Root cause
- Software design
- Action
- An Urgent Voluntary Medical Device Recall notice was sent on 9/30/2015 to all the customers who purchased the Shimadzu C-arm Table (Catalog No. IVS-110). The notification informs the customers of the description of the issue, the actions to be taken by Shimadzu to correct the issue, and the actions to be taken by the customers. Customers with questions or concerns about the device correction, are instructed to contact their local Shimadzu representative or contact Shimadzu National Technical Support at (800) 228-1429.
- Quantity
- 26 units total (4 units in US)
- Distribution
- Worldwide Distribution. US (Texas, Wisconsin, Ohio, and Connecticut), Iran, India, Saudi Arabia, Serbia, Thailand, Germany, Croatia, Turkey, Lebanon, Korea, and China.
- Lot, serial or model codes
- Serial Numbers: 0161H25201 0161H25702 0161H25801 0161H28201 0161H27301 0261H26201 0161H29501 0161H29901 0261H26101 0261H26002 0161H25401 0161H29302 0161H26201 0161H27102 0161H25701 0161H26402 0161H26701 0161H29001 0161H26302 0161H25602 0161H26702 0161H28501 0261H25401 0161H28001 0161H27402 0161H27201
- 510(k) numbers
- ["K963888"]
- PMA numbers
- not on file
- Product code
- JAA
- Firm FEI
- 1000125362
- Firm city
- Torrance
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28